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Study of Pegylated Human Recombinant Arginase for Liver Cancer (BCT-100-002) (BCT-100-002)

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ClinicalTrials.gov Identifier: NCT01092091
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : March 14, 2012
Sponsor:
Collaborators:
The University of Hong Kong
Chinese University of Hong Kong
Information provided by (Responsible Party):
Bio-Cancer Treatment International Limited

Tracking Information
First Submitted Date  ICMJE March 23, 2010
First Posted Date  ICMJE March 24, 2010
Last Update Posted Date March 14, 2012
Study Start Date  ICMJE March 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2010)
Tumor response [ Time Frame: 12 weeks ]
Tumor response endpoints include(a)Objective response for each patient evaluated by RECIST, (b)Modified RECIST criteria will be used as secondary reference, (c) The proportion of patients achieving a partial response or complete response (d) The proportion of patients reporting disease progression by RECIST and the times to progression (e)Serial changes in plasma AFP levels after doses of PEG-BCT-100 and (f)Change in relevant viral serology from baseline to end-of-study
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2010)
  • Plasma arginase and arginine levels [ Time Frame: 12 weeks ]
  • Tumor response [ Time Frame: 12 weeks ]
  • Quality of life [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2010)
  • Overall Survival [ Time Frame: 12 weeks ]
    Overall Survival measurement from the date of starting the first dose of PEG-BCT-100 until death from any cause at every 4 weeks until the patient's death, or 3 months from the last patient's study visit, through clinical visits or telephone follow-ups
  • Time to Progression [ Time Frame: 12 weeks ]
  • Plasma arginase level [ Time Frame: 12 weeks ]
    The PK endpoints include (a) Dose-related peak to trough concentrations of plasma PEG-BCT-100 over time (b)Plasma clearance of PEG-BCT-100; and(c)Intra- and inter-subject variability of plasma PK parameters to assess the predictability of PEG-BCT-100 administration
  • Quality of Life [ Time Frame: 12 weeks ]
    Measurement of Quality of Life by completing 2 questionnaires at baseline, week 8 and 4-weekly after week 8 until end of treatment visit. The Chinese version of the EORTC QLQ-C30 will be used, which contains Five functional scales and Three symptom scales. The Chinese version of EORTC QLQ-HCC18 will also be used.
  • Plasma arginine levels [ Time Frame: 12 weeks ]
    The PD endpoints include (a)The magnitude of plasma arginine depletion relative to the dose (b)The duration of effective ADD assessed by plasma arginine <8 µM relative to the plasma peak and time to clearance (c) The relationships of PEG-BCT-100 dose and its resultant effective ADD to changes in AFP and/or tumor symptoms and measurements(d)The temporal and quantitative relationships of depleted plasma arginine to dose and plasma concentrations of PEG-BCT-100; and (e)Correlation of prolonged arginine depletion with extended survival
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2010)
  • Overall Survival [ Time Frame: 12 weeks ]
  • Time to Progression [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Pegylated Human Recombinant Arginase for Liver Cancer (BCT-100-002)
Official Title  ICMJE Recombinant Human Arginase I (rhArgI) for Patients With Advanced Hepatocellular Carcinoma (HCC)
Brief Summary The purpose of this study is to determine whether recombinant human arginase (PEG-BCT-100) is safe and effective in the treatment of advanced hepatocellular carcinoma (HCC).
Detailed Description

The primary objectives of this study are:

  • To evaluate any objective tumor responses to PEG-BCT-100 in HCC patients receiving weekly doses of PEG-BCT-100 alone.
  • To perform PK and PD analysis
  • To measure Quality of Life of the patients

Secondary objectives of this study are:

  • To define any toxicity associated with the metabolic and cellular alterations of ADD relative to dose and PK of PEG-BCT-100 (rhArgIpeg5000).
  • To confirm the safety and anti-tumor activity of PEG-BCT-100 at the preferred dose (1600U/kg) in 50 patients (at least 18 evaluable subjects) with advanced HCC.
  • To measure duration of response including Overall Survival and Time to Progression analysis
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasm
  • Hepatocellular Carcinoma
Intervention  ICMJE Biological: Pegylated Recombinant Human Arginase I
Weekly dose of PEG-BCT-100 for at least 8 weeks (or until disease progression) at 1600U/kg
Other Name: PEG-BCT-100
Study Arms  ICMJE Experimental: PEG-BCT-100
Pegylated Recombinant Human Arginase I
Intervention: Biological: Pegylated Recombinant Human Arginase I
Publications * Chan SL, Cheng PNM, Liu AM, Chan LL, Li L, Chu CM, Chong CCN, Lau YM, Yeo W, Ng KKC, Yu SCH, Mok TSK, Chan AWH. A phase II clinical study on the efficacy and predictive biomarker of pegylated recombinant arginase on hepatocellular carcinoma. Invest New Drugs. 2021 Apr 15. doi: 10.1007/s10637-021-01111-8. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2012)
20
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2010)
50
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of HCC according to the European Association for the Study of the Liver criteria
  • Known underlying HCC etiology specified by hepatitis B, hepatitis C, post alcoholic cirrhosis, or other
  • HCC lesion(s) which are not resectable and which are measurable by C-T scan
  • Progression of or non-response of HCC lesions after treatments which are considered best standard of care - surgical resection, radiofrequency ablation, chemoembolization
  • No cancer treatment or surgery within the prior 4 weeks, either chemotherapy, targeted biologic or enzymes, either approved or investigational;
  • Males or females from 18 to 75 years-old, inclusive;
  • Ability and willingness to provide written informed consent;
  • Karnofsky performance status of 80% or above and expected survival of more than 12 weeks; and,
  • Negative urine pregnancy test, if female, and willingness to use an effective method of contraception during the entire study period
  • No cognitive impairment
  • Ability to understand and read Chinese

Exclusion Criteria:

  • Advancing liver failure indicated by uncontrolled ascites, pleural effusions, encephalopathy, or a Child-Pugh score of C
  • Significant hepatic, renal or bone marrow dysfunction indicated by total bilirubin >40 µmol/L, evidence of bile duct obstruction, serum albumin <30 g/L, serum SGOT >5 x upper limit of normal, ANC <1.0 x 10^9/L, platelets <100 x 10^9/L, or INR >2.0
  • Significant cardiac or pulmonary disease defined by New York Heart Association (NYHA) Class III or IV, VEF <50% by echo or MUGA, or a history of myocardial infarction within the past 6 months, significant unstable arrhythmia or evidence of ischemia on ECG
  • Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Significant active infection including HIV requiring oral or parenteral anti-infective therapies;
  • Use of investigational drug(s) within 4 weeks of enrollment; or,
  • Prior treatment with arginine depleting agent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01092091
Other Study ID Numbers  ICMJE HKCTR-503C
PR/CT0299/2009 ( Other Identifier: Department of Health, HKSAR )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bio-Cancer Treatment International Limited
Study Sponsor  ICMJE Bio-Cancer Treatment International Limited
Collaborators  ICMJE
  • The University of Hong Kong
  • Chinese University of Hong Kong
Investigators  ICMJE
Principal Investigator: Ronnie TP Poon, Prof Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, The University of Hong Kong
PRS Account Bio-Cancer Treatment International Limited
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP